Clinical trial

A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

NCT02791230

Name

B3461045

Description

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Trial arms

Trial start

2016-06-13

Estimated PCD

2023-10-26

Trial end

2023-11-23

Status

Completed

Phase

Early phase I

Treatment

Tafamidis

Soft gel capsules administered once a day for 60 months

Arms:

Tafamidis

Size

1733

Primary endpoint

All-cause mortality and incidence of treatment emergent adverse events

Baseline to Month 60

Eligibility criteria

Inclusion Criteria: Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028 Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028 Exclusion Criteria: -Liver and/or heart transplant, or implanted cardiac mechanical assist device

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1733, 'type': 'ACTUAL'}}

Updated at

2024-05-03

1 organization

1 product

1 indication

Organization

Pfizer

Product

Tafamidis

Indication

Transthyretin Amyloid Cardiomyopathy